MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RAD-G; OXIMETER

Model Number	9849
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: the returned rad-g was evaluated.The device powered on and off via battery and ac power and was able to obtain measurements with all enabled parameters.No product performance issues related to spo2 and pulse measurement were identified and no power issues were observed during testing.The device was determined to be functioning as designed.Health effect impact code: no adverse event, no patient impact.
Event or Problem Description
The customer reported the rad-g "is turning on and off" and the "readings are inaccurate." no patient impact or consequences were reported.
Event or Problem Description
The customer reported the rad-g "is turning on and off" and the "readings are inaccurate." no patient impact or consequences were reported.
Additional Manufacturer Narrative
Masimo has reached out to the customer to request the return of the device.The product has not been returned to masimo to allow an analysis to be performed. if the product is returned for evaluation or new information is obtained, a follow up report will be submitted.Health effect impact code: no adverse event, no patient impact.

• Brand Name: RAD-G
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 15750 ALTON PKWY; 15750 alton pkwy; irvine CA 92618
• Manufacturer (Section G): MASIMO - MEXICALI; industrial vallera de mexicali calzada del oro, no.2001; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 22499928
• Report Number: 3019388613-2025-00064
• Device Sequence Number: 7217754
• Product Code: DQA
• UDI-Device Identifier: 00843997000666
• UDI-Public: (01)00843997000666(11)240920
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K213676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9849
• Device Catalogue Number: 9849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown